FDA Related News

CDERs Requests for Intarcia Hearing

CDER submits a petition outlining its requests if the FDA chief scientist decides to grant Intarcia a hearing on its NDA for drug/device combination I...

Human Drugs

Karuna Mid-Year NDA Planned for Schizophrenia Drug

Karuna Therapeutics plans a mid-year NDA for schizophrenia drug KarXT (xanomeline-trospium) after reporting positive topline results from a recent Pha...

Marketing

Drug Promotion Research Landscape Analyzed

FDA and RTI International researchers review empirical studies of prescription drug promotion in the last decade and suggest areas for further study.

Medical Devices

Brainomix AI Stroke Tool Cleared by FDA

FDA clears a Brainomix 510(k) for its Brainomix 360 e-ASPECTS artificial intelligence tool for stroke diagnoses.

Medical Devices

Viz.ai Algorithm Cleared for Abdominal Aneurysms

FDA clears a Viz.ai 510(k) for its Viz AAA, an artificial intelligence algorithm intended to detect suspected abdominal aortic aneurysms.

Federal Register

Guide on Pharmacogenomic Data Submissions

Federal Register notice: FDA makes available a draft guidance entitled Pharmacogenomic Data Submissions.

Medical Devices

CDRH Modifies Electronic 510(k) Portal

CDRH adds more functionality to its medical device electronic submission portal to prepare for an all-electronic submission process.

Federal Register

Acufocus IOL Regulatory Review Period

Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for AcuFocus IC8 apthera intraocular lens.

Federal Register

Regulatory Review Period for Jivi

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Bayers hemophilia A therapy Jivi.

Human Drugs

FDA Input on Rare Disease Development Needed: PhRMA

Pharmaceutical Research and Manufacturers of America urges FDA to provide more input on the types of evidence that may be considered in rare disease d...